CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.2005]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.2005 Propofol.

(a) Specifications. Each milliliter of emulsion contains 10 milligrams (mg) propofol.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.

(1) No. 086064 for use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section.

(2) No. 054771 for use as in paragraph (c) of this section.

(c) Conditions of use in dogs and cats - (1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements.

(2) Indications for use. (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; for induction of general anesthesia where maintenance is provided by inhalant anesthetics.

(ii) For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[75 FR 20269, Apr. 19, 2010, as amended at 75 FR 38700, July 6, 2010; 78 FR 17868, Mar. 25, 2013; 79 FR 16195, Mar. 25, 2014; 80 FR 18776, Apr. 8, 2015; 81 FR 36789, June 8, 2016]